People With AIDS Demand Real Expanded Access For Glaxo's New AIDS Drug 1592

June 1997

What is 1592?

Glaxo's new drug, 1592, may be as strong as some of the protease inhibitors. It's from a different family of AIDS drugs, called nucleosides. For people who have taken all the AIDS drugs -- 1592 may be their only hope.

GLAXO'S Underwhelming Proposal

Glaxo, the company that makes AZT and 3TC, has proposed a pathetically limited "compassionate use" program for July.First the good news -- the drug will be available for kids.Now the bad news -- total enrollment is limited to only 2,500 people worldwide. There won't be anywhere near enough drug available for the kids or adults who need it. Is everybody happy?

What's Going On?

Glaxo offers a small amount of drug this summer. They've said they hope to open a second small "expanded access" program in January '98 and get FDA approval in March '98. At that point, Glaxo will close these programs and send everyone to their local drug store. It looks like Glaxo wants to cheaply collect some safety data (70% nausea in early trials), and when FDA approval looks close, get more doctors familiar with the drug. The result of this strategy? Glaxo gets months of pre-approval publicity, and virtually nobody gets access to 1592. Great deal! Marketing, not compassion.

We know that Glaxo can run a large expanded access program -- look at their 3TC program. People with AIDS have been asking Glaxo for early access to 1592 for over a year. The drug has been "in development" for nine years and it's cheap to make! They say they have a supply problem -- which happens if you don't bother to produce drug. Could it be that Glaxo is stalling to preserve their AZT and 3TC sales?

What Have We Been Fighting For?

Parallel Track - a way to collect safety data and save lives. Until 1990, drugs were only available after FDA approval. People with AIDS and advocates poured energy and resources into successfully demanding lifesaving expanded access programs from the drug industry. FDA regulations were changed so that as soon as minimal data was available, companies were allowed to offer new drugs through large expanded access programs, called parallel track, while the drug continued to be tested in clinical trials.

1989-91: With promising data on about 100 people, ddI is made available to over 23,000 people in the United States, the first large expanded access program.

1990-91: The first "parallel track" program begins (actually, a dose-comparison program), getting ddC to 5,186 people prior to the drug's approval.

1992-94: The expanded access program for d4T allows early access to the drug for 12,477 people in the United States.

1995: Glaxo provides 3TC to over 32,000 people in the United States, the largest expanded access program ever.

Since then, drug companies have acted in bad faith, using these programs for public relations and marketing campaigns -- running lotteries and claiming fictitious supply problems. Some examples:1995: Remember Roche's lottery? 2,000 slots were filled in July, and then another 2,000 slots were announced in the fall, one month prior to approval, when most of the July "winners" still hadn't gotten drug. How many of the "winners" got any drug before FDA approval?1995: What about the Abbott 2,000 person Ritonavir lottery? The lottery took place three months before approval. Only 1,480 people got drug, and most for only a month. Did anyone win?1995: Merck announces a Crixivan lottery for 1100 people in the US and an additional 750 for the rest of the world! Merck is only now getting the drug into pharmacies, still limiting their supply, still citing production difficulties. Who can believe when one of the world's largest drug companies has over a year of production difficulties? How (in)competent can this company be?

People with AIDS organized large demonstrations in the 1980s, and secured large programs giving tens of thousands of PWAs access to life-saving antivirals. Now we're at a point where drug companies see us only as pawns for their growing "AIDS market." AIDS is still a matter of life and death. We deserve better.

This article was provided by PWA Health Group.
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